Recall Ledger

Ami HTX recall (Spectral Instruments Inc)

Medical deviceClass IIOngoing

Summary: Spectral Instruments Inc is recalling Ami HTX. Reason: Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

What is being recalled

Ami HTX

Why

Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

United States.

How to tell if yours is affected

All serial numbers.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2940-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJuly 24, 2026
ReportedAugust 26, 2026
CompanySpectral Instruments Inc
Company locationTucson, AZ, United States
Initiated byFDA Mandated
Quantity35

More recalls from Spectral Instruments Inc · all medical device recalls · recalls from July 2026

Official FDA record